This blog replaces the earlier archives I had posted on the Internet and includes various memos sent to the clients of the VitaminLawyer.com (now the Vitamin Consultancy). It includes archived copies of memos from 2004 through 2007 and subsequent memos will be posted as they are issued.

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From an FDA warning letter issued last week: "...FDA's focus on fraudulent products marketed on the Internet for serious and life-threatening diseases. Individuals and firms that do not resolve violations of the Federal Food, Drug, and Cosmetic Act risk injunction to halt the illegal activities, seizure of violative products, and other regulatory sanctions."
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2. News Bits…

From New Hope Media: Dietary ingredient shortage!

“Retailers may have to start charging their customers more for dietary supplements containing vitamin C by the end of the year as manufacturers are forced to pass on higher prices from suppliers. Prices for vitamin C are ballooning because of supply shortages out of China, the world's primary supplier, and the use of corn, a source of vitamin C for mass production, as a biofuel, said Ed Keenan, vice president of marketing at New York-based supplements manufacturer, FutureBiotics. Keenan said Chinese suppliers claim they are shutting down plants to remodel them to meet Western standards of production. China supplies about three quarters of the global vitamin C market. "What they've done is squeeze production. They're holding back in their production," Kennan said of the Chinese production companies. "The whole industry is going to be hit by a severe shortage."
http://www.functionalingredientsmag.com/fimag/articleDisplay.asp?strArticleId=1436&strSite=FFNSite

AHPA Speaks Out:

The American Herbal Products Association has submitted comments to the US Food and Drug Administration, urging it to assist the dietary supplement industry in complying with good manufacturing practices, adverse event reporting, and new dietary ingredient safety regulations. The Maryland-based association was responding to calls for input from the FDA's Center for Food Safety and Applied Nutrition.

"The dietary supplement industry faces two major new regulatory requirements, as does the agency: a final rule on current good manufacturing practice for manufacturing, packaging, labeling, and holding dietary supplements, which were released this past June, and the Dietary Supplement and Nonprescription Drug Consumer Protection Act, a new law requiring serious adverse event reports associated with dietary supplements and over-the counter drugs be submitted to the FDA, which goes into effect this December," AHPA stated.

NAC & Gambling:“A common amino acid sold as a dietary supplement could help diminish pathological gambling addictions, according to a new study. Researchers at the University of Minnesota uncovered the link following an eight-week trial involving 27 people who were given increasing doses of N-acetyl cysteine. By the end of the pilot study, published in the September 15th issue of Biological Psychiatry, 60 percent of the participants reported having less urges to gamble. The potential significance of these findings is huge - given the widespread damage caused by addictive gambling.”

“The US government yesterday concluded a hearing examining the implementation of a nation-wide food labeling system to provide consistent nutrition information on product labels. .. FDA this week held a two-day meeting to gather comments from industry, health groups, advocacy organizations and medical experts on the use of a labeling program similar to the UK's traffic light system. Indeed, a number of countries around the world have already instituted voluntary labeling systems for government-designed nutrition symbols. These symbol systems vary in their format. Some systems have detailed graphic illustrations that indicate the content of a number of selected nutrients, while others simply present a single icon indicating that a food is healthful, with further information available elsewhere, such as in booklets and web sites. In the US, the food and beverage industry has identified the need to spell things out simply for consumers..”

http://www.nutraingredients-usa.com/news/ng.asp?n=79708&m=1NIU912&c=jegwylrviswtnqa
And this, from Nutrition 21, indicating that the middlemen are moving into marketing as the new GMPs become effective.

“Nutrition 21, the developer of chromium-based Chromax, announced it has entered into definitive agreements to privately place shares and warrants to fund $17.75mn for marketing and retailing of its condition-specific products. The New York state-based company previously used its science portfolio to support branded ingredient Chromax's use in supplements. However, the company has opted for a change in direction and invested heavily in promoting Chromax directly as a finished supplement product through food, drug and mass retail outlets. The company is going to attempt to take the market by storm, because it says its products have the potential to be attractive to a wide variety of consumers.”

About Me

The Vitamin Conslutancy - www.vitaminconsultancy.com -- I practiced law for 36 years in NJ (1971 - 2006), gaining a reputation as The Vitamin Lawyer, representing people in the Natural Products, Dietary Supplements and CAM (Complementary and Alternative Modalities) fields. Now I provide educational services and I consult with lawyers and other professionals, formulators, manufacturers and purveyors of natural and nutritional products, as well as with CAM enterprises and practitioners.
I started these blogs to comment on health and freedom issues and to provide an archive of information for my clients and associates. This is a private expressive association communication.
I have been a trustee of several NGOs (nongovernmental organizations) including the Natural Solutions Foundation - globalhealthfreedom.org - Institute for Health Research - inhere.org - Sound Health Research Institute - soundhealthresearch.org and LifeSpirit Church - lifespirit.org